quality engineer salaries in boston, massachusetts

job summary: A Quality Engineer is needed for an American medical technology company primarily focused on women's health, selling medical devices for diagnositcs, surgery, and medical imaging, in the Marlborough, MA area. This role requires a candidate with an engineering degree and 2 to 4 years of medical device experience to manage nonconforming event investigations, oversee equipment calibrations, and ensure regulatory compliance with ISO 13485 and FDA standards within a capital equipment manufacturing environment.   location: Marlborough, Massachusetts job type: Contract salary: $44 - 46 per hour work hours: 8am to 4pm education: Bachelors   responsibilities: Support daily manufacturing quality control and regulatory compliance for medical device capital equipment.Lead nonconforming event (NCE) investigations to evaluate the impact of materials on product quality and compliance.Determine containment actions, conduct root cause investigations, and assess risk for nonconforming materials.Collaborate with cross-functional stakeholders to determine product disposition and necessary escalation activities.Monitor quality data to identify trends and proactively initiate corrective actions to address unfavorable patterns.Assess equipment controls, including validation, calibration, and preventative maintenance.Conduct out of tolerance investigations and approve equipment records to ensure the validity of manufactured devices.Support process FMEA development and participate in Corrective and Preventive Action (CAPA) activities.Assist with New Product Introduction (NPI), design transfer, and the execution of process and test method validations.Review and develop quality and engineering documentation, procedures, and change orders.Ensure adherence to safety regulations, Standard Operating Procedures (SOPs), and Good Documentation Practices (GDP).Participate in continuous improvement and lean thinking initiatives to enhance operational efficiency. Qualifications: Bachelor's Degree in Engineering or a related discipline, or an equivalent combination of education and experience.2 to 4 years of experience as a quality professional specifically within the medical device industry.strong knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP.Experience with Class II and III medical devices or IVD device capital equipment is preferred.Proven ability to resolve quality issues through root cause analysis and sustainable corrective actions.Experience with statistical tools and methodologies such as Six Sigma, SPC, and DOE. Other Requirements: Understanding of risk management principles, including ISO 14971 and pFMEA.Proficiency in using Quality Management Systems (QMS) and enterprise software systems.strong technical writing skills for preparing and reviewing complex technical documentation.Commitment to integrity, accountability, and a customer-focused mindset.Ability to operate with a sense of urgency and maintain proactive communication with stakeholders.Participation in regular training and a commitment to meeting all training deadlines.Alignment with company values regarding sustainability, inclusion, and operational excellence.   qualifications: Experience level: ExperiencedEducation: Bachelors  skills: Quality Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

job summary: Seeking a highly resourceful Quality / Test Engineer for a long term contract position in the Billerica, MA area. This person is needed to evaluate existing test methods and procedures to determine how they might be improved. The right person will analyze test data using statistical methods in Excel and/or JMP and report on results in both Confluence and Jira. The person will have proven experience identifying gaps in test plans and the ability to communicate and share ideas with internal teams. If this sounds like you, apply now for this great opportunity!   location: BURLINGTON, Massachusetts job type: Contract salary: $35 - 45 per hour work hours: 8am to 5pm education: Bachelors   responsibilities: Update and create test protocols for new featuresSupports product validationUse MS Excel to analyze test data using statistical methodsReport results using both Confluence and JiraLeverage Jira data to compile reports on testing status across multiple programs to report to leadershipMaintaining documentation needed to support testing execution, including data capture forms and digital requestsReview test plans, identify gaps, and collaborate with multiple teams to confirm test completion. Qualifications Technical degree with 3+ minumum related Quality and Testing analysis experience Proficiency using MS Excel or JMP for statistical analysisExperience using Confluence and Jira data centerMaintains excellent organizational and documentation skills with great attention to detail Collaborates well with others and possesses top-notch communication skills   qualifications: Experience level: ExperiencedMinimum 4 years of experienceEducation: Bachelors (required)  skills: JIRAQualityConfluence Data CenterStatistical AnalysisProduct ValidationTest Analysis Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

**This is a 6-month co-op starting July 6th and going through December 18th. Must have transportaion to go onsite in Danvers, MA** In partnership with MilliporeSigma, we are seeking candidates actively enrolled in an accredited University for the duration of the co-op assignment. Seeking rising a Junior or Senior in a Bachelor’s Degree program or equivalent, studying an Engineering discipline; preferably Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, or Biomedical Engineering. The work will be completed on-site in Danvers, MA.  We are seeking persons to support Product Engineering projects for our Mobius Single Use franchise, within Integrated Supply Chain Operations. The position is located at our manufacturing site in Danvers, Massachusetts. Mobius products are used in pharmaceutical bioprocessing and include a variety of highly differentiated configurations and sizes. Every assembly we manufacture has been specially designed to meet a certain application for a specific customer. The Product Engineering Team’s primary function is to deliver innovative and effective solutions for both our external and internal customers, while also serving as a bridge between the marketing unit (Product Management, Sales, and Field Marketing) and operations. salary: $25 - $32 per hourshift: Firstwork hours: 8 AM - 4 PMeducation: High SchoolResponsibilitiesThis position will serve as a valuable resource, gathering data critical to supporting the Product Engineering team in their efforts to meet product requirements. Responsibilities include: Contact suppliers/manufacturers to gather available data on Mobius components and packaging systems Coordinate sample builds, conduct in house testing, coordinate external product and packaging testing, perform data analysis on test results Write required documents from templates (Purchase Specifications and Validation Protocols/Reports) Create CAD models in SolidWorks Develop custom product packaging designs Create/update drawings based on customer and/or plant requirements Submit documents to Quality Documentation System Conduct research on new technologies, components, packaging Summarize and present project updates to leadership on a regular basis SkillsEngineering (6 months of experience is preferred)QualificationsYears of experience: 0 yearsExperience level: Entry LevelRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.